A Phase 1 interventional study of BL22 immunotoxin in Leukemia, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-29.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.
PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 courses in the absence of disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.
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DISEASE CHARACTERISTICS:
Histologically confirmed refractory or recurrent hairy cell leukemia
Must have at least one of the following indications for therapy:
Cytopenia defined by the following:
Evidence of CD22 positivity by 1 of the following:
No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
This study is completed, as verified in Jan 2006. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)